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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K213777
Device Name Stryker Resorbable Fixation System
Applicant
Stryker Leibinger Micro Implants
750 Trade Centre Way -Suite 200
Portage,  MI  49002
Applicant Contact Gregory Gohl
Correspondent
Stryker Leibinger Micro Implants
750 Trade Centre Way -Suite 200
Portage,  MI  49002
Correspondent Contact Gregory Gohl
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Codes
GXR   HBW  
Date Received12/03/2021
Decision Date 02/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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